Resp-O2 Small Volume Nebulizer

GUDID 00840117317994

Resp-O2 Small Volume Nebulizer 6cc Cup 7' (2.1m) Tubing, Standard Connector, 45 Degrees Pacifier Elbow, Infant/Toddler

DYNAREX CORPORATION

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• Primary Device ID: 00840117317994
• NIH Device Record Key: 8b4c84fe-5daf-451c-9bd1-b123b6968779
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Resp-O2 Small Volume Nebulizer
• Version Model Number: 34107
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840117311916 [Primary]
GS1	00840117311923 [Package]; Package: Shipper [12 Units]; In Commercial Distribution
GS1	00840117317994 [Package]; Contains: 00840117311916; Package: Box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150591

FDA Product Code

• CAF: Nebulizer (Direct Patient Interface)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-30
• Device Publish Date: 2021-04-22

On-Brand Devices [Resp-O2 Small Volume Nebulizer]

• 00840117311961: Resp-O2 Small Volume Nebulizer 6cc Cup w/Pediatric Aerosol Elongated Mask 7' (2.1m) Tubing, Univ
• 00840117311947: Resp-O2 Small Volume Nebulizer 6cc Cup w/ Adult Aerosol Elongated Mask 7' (2.1m) Tubing Universa
• 00840117317994: Resp-O2 Small Volume Nebulizer 6cc Cup 7' (2.1m) Tubing, Standard Connector, 45 Degrees Pacifier
• 00840117311909: Resp-O2 Small Volume Nebulizer 6cc Cup 7' (2.1m) Tubing, Universal Connector T-Piece Mouthpiece,
• 00840117311886: Resp-O2 Small Volume Nebulizer 6 cc Cup 7' (2.1m) Tubing, Standard Connector with Spring Loaded
• 00840117311862: Resp-O2 Small Volume Nebulizer 6 cc Cup, 7' (2.1) Tubing, Standard Connector w/ Spring loaded T
• 00840117311848: Resp-O2 Small Volume Nebulizer 6cc Cup 7' (2.1m) Tubing, Standard Connector
• 00840117311824: Resp-O2 Small Volume Nebulizer 6cc Cup
• 00840117308688: Resp-O2 Small Volume Nebulizer 6cc Cup with Pediatric Aerosol Elongated Mask 7' (2.1m) Tubing, S
• 00840117308664: Resp-O2 Small Volume Nebulizer 6cc Cup with Adult Aerosol Elongated Mask 7' (2.1m) Tubing, Stand
• 00840117308640: Resp-O2 Small Volume Nebulizer 6cc Cup 7' (2.1m) Tubing, Standard Connector T-piece, mouthpiece,
• 00840117308626: Resp-O2 Small Volume Nebulizer 6cc Cup 7' (2.1m) Tubing, Standard Connector, T-Piece; mouthpiece